Efficacy, safety and tolerability of serelaxin when added to standardtherapy in Asian patients with acute heart failure (AHF)
- Conditions
- Health Condition 1: null- Acute Heart Failure
- Registration Number
- CTRI/2016/05/006952
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 1520
•Male or female >= 18 years of age, with body weight <=160 kg
Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and the end of screening:
â?¦Dyspnea at rest or with minimal exertion
â?¦Pulmonary congestion on chest radiograph
â?¦Brain natriuretic peptide (BNP) >=350 pg/mL or NT-proBNP >=1,400 pg/mL
•Systolic BP >=125 mmHg at the start and at the end of screening
•Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
•Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of >= 25 and <=75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines).
Dyspnea primarily due to non-cardiac causes.
Temperature 38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with a clinical composite endpoint of treatment success, treatment failure, or no change.Timepoint: Treatment success at Day 2, Treatment failure through Day 5, and No change through Day 5
- Secondary Outcome Measures
Name Time Method Time to all-cause death.Time to event is computed as the number of days from randomization to all cause deathTimepoint: Through Day 180;Time to cardiovascular death.Time to event is computed as the number of days from randomization to cardiovascular death <br/ ><br> <br/ ><br>Timepoint: Through Day 180;Time to Worsening Heart Failure.Time to event is computed as the number of days from randomization to Worsening Heart FailureTimepoint: Through Day 5